A Phase 3 interventional study of Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody and Carboplatin in Carcinoma, Non-Squamous Non-Small Cell Lung, sponsored by Hoffmann-La Roche. Completed at 132 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-09.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).
6,491 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,633 are open to participants now.
This study's enrollment of 723 is above the median of 62 across 5,216 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Cancer-Specific Exclusions:
General Medical Exclusions:
Exclusion Criteria Related to Medications:
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurred first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody · Drug: Carboplatin · Drug: Nab-Paclitaxel
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurred first during induction treatment phase. Participants received best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. Participants who were consented prior to approval of protocol Version 5 were given the option to cross over to receive atezolizumab as monotherapy until disease progression.
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody · Drug: Carboplatin · Drug: Nab-Paclitaxel · Drug: Pemetrexed
Atezolizumab was administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Atezolizumab was administered to participants who were randomized to "Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin)" and to participants in "Arm B (Nab-Paclitaxel + Carboplatin)" who cross over at progression.
Also known as: MPDL3280A, RO5541267, Tecentriq
Carboplatin was administered at area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.
Nab-paclitaxel was administered as IV infusion at a dose of 100 milligrams per square meter (mg/m\^2) on Days 1, 8, and 15 of each 21-day cycle.
Switch maintenance to pemetrexed can be administered within 6 weeks of Day 1 of the last induction cycle.
Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the ITT-WT Population
PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first in the ITT-WT population.
Time frame: Up to approximately 35 months after first patient enrolled
Overall Survival (OS) in the ITT-WT Population
OS is defined as the time between the date of randomization and date of death from any cause in the ITT-WT population.
Time frame: Up to approximately 35 months after first patient enrolled
PFS as Determined by the Investigator Using Recist v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population
PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
Time frame: Up to approximately 35 months after first subject enrolled
OS as Determined by the Investigator Using Recist v1.1 in the ITT Population
OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.
Time frame: Up to approximately 41 months after first subject enrolled
OS as Determined by the Investigator Using RECIST v1.1 in the PD-L1 Expression Population and PD-L1 Expression WT Population
OS is defined as the time between the date of randomization and date of death from any cause in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
Time frame: Up to approximately 35 months after first patient enrolled
Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT-WT Population
ORR (confirmation not required) is defined as the proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by the investigator in the ITT-WT population.
Time frame: Up to approximately 41 months after first subject enrolled
Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population
ORR (confirmation not required) is defined as proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by investigator in ITT population, PD-L1 Expression population, and PD-L1 Expression WT population. ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. PD-L1 expression WT population is defined as PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
Time frame: Up to approximately 35 months after first subject enrolled
Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 in ITT-WT Population, ITT Population, and PD-L1 Expression Population and PD-L1 Expression WT Population
DOR,defined for participants with objective response (OR) as time from 1st documented OR to documented disease progression as determined by investigator using RECIST v1.1,or death from any cause,whichever occurs 1st.ITT defined as all randomized participants,regardless of receipt of assigned treatment.ITT-WT defined as ITT population excluding participants with activating EGFR mutation or ALK translocation.PD-L1 expression population is defined as one of following:PD-L1 IHC TC1/2/3 or IC1/2/3 population,defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue;PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue;PD-L1 IHC TC3 or IC3 population,defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue.PD-L1 expression WT is defined as PD-L1 expression population excluding participants with activating EGFR mutation or ALK translocation.
Time frame: Up to approximately 35 months after first subject enrolled
Event Free Rate (%) at Year 1 and 2 in ITT-WT Population and ITT Population
The OS rate at the 1- and 2-year landmark time points after randomization.
Time frame: Up to 41 months after first patient enrolled, years 1 and 2 reported
Event Free Rate (%) at Year 1 and 2 in PD-L1 Expression Population and PD-L1 Expression WT Population
The OS rate at the 1- and 2-year landmark time points after randomization in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
Time frame: Up to 35 months after first patient enrolled, years 1 and 2 reported
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT Population
Defined as time from randomization to confirmed deterioration (10-point change) on the combined European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30) and supplemental lung cancer module (EORTC QLQ-LC13) symptom subscales.
Time frame: Up to approximately 35 months after first subject enrolled
Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale
Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms \& are scored at individual symptom level, thus have a dyspnea score, chest pain score, \& cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 \& maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 \& 2, 'Cough' score is mean of question 3 \& 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea \& cough symptom scores is considered to be clinically significant; whereas a score change of≥0.5 points for chest pain score is considered to be clinically significant.
Time frame: Up to approximately 35 months after first subject enrolled
Percentage of Participants With Adverse Events
Percentage of participants with at least one adverse event. Adverse event onset date before cross over.
Time frame: Up to approximately 69 months after first patient enrolled
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B Carboplatin+nab-paclitaxel Crossover Participants
Time frame: Up to approximately 35 months after first subject enrolled
Maximum Observed Serum Concentration (Cmax) of Atezolizumab for Patients in Atezolizumab+Carboplatin+Nab-Paclitaxel Arm
Predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.
Time frame: Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length = 21 days)
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Atezolizumab+Carboplain+Nab-Paclitaxel
Predose samples will be collected on the same day of treatment administration.
Time frame: Cycle 1 Day 21, Cycle 2 Day 21, Cycle 3 Day 21, and Cycle 7 Day 21 (Cycle length = 21 days)
Plasma Concentrations of Carboplatin
Time frame: Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 hour after carboplatin infusion (infusion duration=15 to 30 minutes) on Day 1 of Cycle 1 and 3 (1 Cycle=21 days) (up to approximately 35 months)
Plasma Concentrations of Nab-Paclitaxel Reported as Total Paclitaxel
Time frame: Predose (same day of treatment administration), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after nab-paclitaxel infusion (infusion duration=30 minutes) on Day 1 of Cycle 1 and 3 (1 Cycle=21 days) (up to approximately 35 months)
| Milestone | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
|---|---|---|
| Started | 483 | 240 |
| Completed | 0 | 0 |
| Not completed | 483 | 240 |
| Withdrew: Withdrawal by subject | 20 | 13 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Physician decision | 7 | 0 |
| Withdrew: Randomized in error | 5 | 4 |
| Withdrew: Non-compliance | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Death | 330 | 176 |
| Withdrew: Patient moving to roll-over study | 17 | 5 |
| Withdrew: Prolonged hospitalization | 1 | 0 |
| Withdrew: Death prior first dose | 1 | 0 |
| Withdrew: Administrative-change facility | 1 | 0 |
| Withdrew: Request from sponsor to withdraw patient in survival follow-up | 78 | 29 |
| Withdrew: Patient moved to commercial atezolizumab use | 14 | 9 |
| Withdrew: Study terminated by sponsor | 3 | 1 |
| Withdrew: Patient admitted to hospital & couldn't be dosed for randomization | 1 | 0 |
| Withdrew: Sponsor decision | 2 | 0 |
| Withdrew: 3 year treatment completed, immunotherapy paused, continuing follow-up planned | 1 | 0 |
PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first in the ITT-WT population.
| Months | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
|---|---|---|
| Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the ITT-WT Population | 7.0 (6.3 to 7.3) | 5.5 (4.4 to 5.9) |
OS is defined as the time between the date of randomization and date of death from any cause in the ITT-WT population.
| Months | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
|---|---|---|
| Overall Survival (OS) in the ITT-WT Population | 18.6 (15.8 to 21.2) | 13.9 (12.0 to 18.7) |
PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
| Months | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
|---|---|---|
| ITT Population | 7.0 (6.3 to 7.3) | 5.6 (4.5 to 5.9) |
| TC1/2/3 or IC1/2/3 ITT Population | 7.5 (7.0 to 9.1) | 5.7 (4.5 to 6.6) |
| TC1/2/3 or IC1/2/3-WT ITT Population | 7.5 (7.0 to 9.0) | 5.9 (4.5 to 6.6) |
OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.
| Months | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
|---|---|---|
| OS as Determined by the Investigator Using Recist v1.1 in the ITT Population | 17.0 (14.9 to 19.7) | 13.5 (11.9 to 17.7) |
OS is defined as the time between the date of randomization and date of death from any cause in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
| Months | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
|---|---|---|
| TC1/2/3 or IC1/2/3 ITT Population | 21.2 (17.3 to 28.2) | 16.9 (12.5 to 22.0) |
| TC1/2/3 or IC1/2/3 WT ITT Population | 21.2 (18.1 to 28.2) | 16.9 (12.5 to 22.0) |
ORR (confirmation not required) is defined as the proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by the investigator in the ITT-WT population.
| Percentage of participants | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
|---|---|---|
| Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT-WT Population | 60.2 | 41.0 |
ORR (confirmation not required) is defined as proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by investigator in ITT population, PD-L1 Expression population, and PD-L1 Expression WT population. ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. PD-L1 expression WT population is defined as PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
| Percentage of participants | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
|---|---|---|
| ITT Population | 59.1 | 42.2 |
| TC1/2/3 or IC1/2/3 ITT WT Population | 65.6 | 46.2 |
| TC1/2/3 or IC1/2/3 ITT Population | 64.6 | 45.0 |
DOR,defined for participants with objective response (OR) as time from 1st documented OR to documented disease progression as determined by investigator using RECIST v1.1,or death from any cause,whichever occurs 1st.ITT defined as all randomized participants,regardless of receipt of assigned treatment.ITT-WT defined as ITT population excluding participants with activating EGFR mutation or ALK translocation.PD-L1 expression population is defined as one of following:PD-L1 IHC TC1/2/3 or IC1/2/3 population,defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue;PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue;PD-L1 IHC TC3 or IC3 population,defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue.PD-L1 expression WT is defined as PD-L1 expression population excluding participants with activating EGFR mutation or ALK translocation.
| Months | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
|---|---|---|
| ITT Population | 6.2 (5.6 to 7.9) | 5.4 (4.1 to 5.8) |
| ITT-WT Population | 6.7 (5.6 to 8.0) | 5.4 (3.9 to 5.8) |
| TC1/2/3 or IC1/2/3 ITT Population | 7.2 (5.7 to 9.0) | 5.0 (3.2 to 6.1) |
| TC1/2/3 or IC1/2/3 ITT WT Population | 7.2 (5.7 to 9.0) | 5.0 (3.2 to 6.1) |
The OS rate at the 1- and 2-year landmark time points after randomization.
| Percentage of participants | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
|---|---|---|
| Event Free Rate (%) at Year 1 ITT WT | 62.02 (57.53 to 66.51) | 54.56 (48.04 to 61.08) |
| Event Free Rate (%) at Year 2 ITT WT | 40.43 (35.64 to 45.22) | 32.36 (25.80 to 38.92) |
| Event Free Rate (%) at Year 1 ITT | 61.65 (57.29 to 66.02) | 54.47 (48.09 to 60.84) |
| Event Free Rate (%) at Year 2 ITT | 39.73 (35.10 to 44.37) | 32.21 (25.79 to 38.63) |
The OS rate at the 1- and 2-year landmark time points after randomization in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor tissue. The PD-L1 expression WT population is defined as the PD-L1 expression population excluding participants with an activating EGFR mutation or ALK translocation.
| Percentage of participants | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
|---|---|---|
| Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT | 68.56 (62.46 to 74.66) | 61.86 (52.55 to 71.17) |
| Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT | 44.63 (35.99 to 53.27) | 35.98 (23.25 to 48.72) |
| Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT WT | 68.84 (62.56 to 75.13) | 62.51 (53.07 to 71.94) |
| Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT WT | 44.02 (34.86 to 53.18) | 35.33 (22.06 to 48.60) |
Defined as time from randomization to confirmed deterioration (10-point change) on the combined European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30) and supplemental lung cancer module (EORTC QLQ-LC13) symptom subscales.
| Months | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
|---|---|---|
| Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT Population | 2.2 (1.8 to 3.1) | 1.9 (1.5 to 2.4) |
Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms \& are scored at individual symptom level, thus have a dyspnea score, chest pain score, \& cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 \& maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 \& 2, 'Cough' score is mean of question 3 \& 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea \& cough symptom scores is considered to be clinically significant; whereas a score change of≥0.5 points for chest pain score is considered to be clinically significant.
| Units on a scale | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
|---|---|---|
| Chest Pain, Week 1 | 0.19 ± 0.86 | 0.14 ± 0.90 |
| Chest Pain, Week 2 | -0.02 ± 0.89 | 0.03 ± 0.91 |
| Chest Pain, Week 3 | -0.05 ± 0.95 | 0.01 ± 0.92 |
| Chest Pain, Week 4 | -0.11 ± 0.95 | 0.01 ± 1.02 |
| Chest Pain, Week 5 | -0.12 ± 0.99 | 0.00 ± 1.03 |
| Chest Pain, Week 6 | -0.24 ± 1.07 | 0.03 ± 1.03 |
| Chest Pain, Week 7 | -0.23 ± 1.11 | 0.03 ± 1.08 |
| Chest Pain, Week 8 | -0.21 ± 0.99 | -0.14 ± 1.00 |
| Chest Pain, Week 9 | -0.18 ± 1.07 | -0.01 ± 1.07 |
| Chest Pain, Week 10 | -0.10 ± 1.07 | -0.07 ± 1.01 |
| Chest Pain, Week 11 | -0.11 ± 1.14 | 0.01 ± 0.96 |
| Chest Pain, Week 12 | -0.15 ± 1.09 | -0.10 ± 1.13 |
| Chest Pain, Week 13 | -0.26 ± 1.07 | -0.03 ± 1.02 |
| Chest Pain, Week 14 | -0.28 ± 1.08 | -0.17 ± 1.18 |
| Chest Pain, Week 15 | -0.26 ± 1.14 | -0.19 ± 1.19 |
| Chest Pain, Week 16 | -0.33 ± 1.11 | -0.16 ± 1.20 |
| Chest Pain, Week 17 | -0.33 ± 1.11 | -0.14 ± 1.13 |
| Chest Pain, Week 18 | -0.28 ± 1.08 | -0.07 ± 1.13 |
| Chest Pain, Week 19 | -0.28 ± 1.04 | -0.16 ± 1.00 |
| Chest Pain, Week 20 | -0.26 ± 1.03 | -0.22 ± 1.02 |
| Chest Pain, Week 21 | -0.25 ± 1.04 | -0.32 ± 1.08 |
| Chest Pain, Week 22 | -0.28 ± 1.01 | -0.11 ± 1.03 |
| Chest Pain, Week 23 | -0.24 ± 1.03 | -0.19 ± 1.04 |
| Chest Pain, Week 24 | -0.21 ± 1.01 | -0.43 ± 1.03 |
| Chest Pain, Week 25 | -0.20 ± 0.98 | -0.24 ± 1.07 |
| Chest Pain, Week 26 | -0.17 ± 1.01 | -0.13 ± 0.91 |
| Chest Pain, Week 27 | -0.22 ± 1.01 | -0.15 ± 1.17 |
| Chest Pain, Week 28 | -0.20 ± 0.98 | -0.07 ± 0.91 |
| Chest Pain, Week 29 | -0.27 ± 1.09 | -0.04 ± 0.92 |
| Chest Pain, Week 30 | -0.15 ± 1.06 | -0.28 ± 1.12 |
| Chest Pain, Week 31 | -0.16 ± 0.95 | -0.12 ± 1.05 |
| Chest Pain, Week 32 | -0.19 ± 0.89 | -0.30 ± 1.10 |
| Chest Pain, Week 33 | -0.18 ± 1.00 | -0.18 ± 1.11 |
| Chest Pain, Week 34 | -0.18 ± 1.07 | -0.17 ± 1.18 |
| Chest Pain, Week 35 | -0.10 ± 1.09 | 0.05 ± 1.06 |
| Chest Pain, Week 36 | -0.21 ± 1.08 | -0.35 ± 1.01 |
| Chest Pain, Week 37 | -0.18 ± 1.18 | -0.10 ± 1.04 |
| Chest Pain, Week 38 | -0.32 ± 1.02 | -0.05 ± 1.01 |
| Chest Pain, Week 39 | -0.28 ± 0.90 | -0.22 ± 1.06 |
| Chest Pain, Week 40 | -0.19 ± 0.87 | -0.39 ± 0.81 |
| Chest Pain, Week 41 | -0.25 ± 0.93 | -0.19 ± 0.89 |
| Chest Pain, Week 42 | -0.16 ± 1.02 | -0.41 ± 0.74 |
| Chest Pain, Week 43 | -0.24 ± 0.90 | -0.22 ± 0.95 |
| Chest Pain, Week 44 | -0.24 ± 0.95 | 0.00 ± 0.98 |
| Chest Pain, Week 45 | -0.14 ± 0.95 | -0.07 ± 0.78 |
| Chest Pain, Week 46 | -0.15 ± 0.94 | -0.07 ± 1.03 |
| Chest Pain, Week 47 | -0.22 ± 0.98 | -0.15 ± 0.90 |
| Chest Pain, Week 48 | -0.14 ± 0.91 | -0.18 ± 0.98 |
| Chest Pain, Week 49 | -0.22 ± 0.91 | -0.72 ± 0.75 |
| Chest Pain, Week 50 | -0.18 ± 0.91 | -0.19 ± 0.70 |
| Chest Pain, Week 51 | -0.13 ± 0.71 | -0.50 ± 0.78 |
| Chest Pain, Week 52 | -0.15 ± 0.83 | -0.36 ± 0.63 |
| Chest Pain, Week 53 | -0.20 ± 0.82 | -0.33 ± 0.61 |
| Chest Pain, Week 54 | -0.22 ± 0.87 | -0.21 ± 0.70 |
| Chest Pain, Week 55 | -0.34 ± 0.80 | -0.30 ± 0.76 |
| Chest Pain, Week 56 | -0.19 ± 0.95 | -0.33 ± 0.68 |
| Chest Pain, Week 57 | -0.19 ± 0.76 | -0.40 ± 0.65 |
| Chest Pain, Week 58 | -0.32 ± 0.92 | -0.50 ± 1.15 |
| Chest Pain, Week 59 | -0.25 ± 0.93 | -0.63 ± 0.75 |
| Chest Pain, Week 60 | -0.27 ± 1.03 | -0.50 ± 1.08 |
| Chest Pain, Week 61 | -0.28 ± 1.02 | -0.20 ± 1.15 |
| Chest Pain, Week 62 | -0.16 ± 1.06 | -0.40 ± 1.47 |
| Chest Pain, Week 63 | -0.12 ± 0.82 | -0.10 ± 1.34 |
| Chest Pain, Week 64 | -0.15 ± 0.83 | 0.38 ± 1.44 |
| Chest Pain, Week 65 | -0.31 ± 0.84 | 0.17 ± 1.76 |
| Chest Pain, Week 66 | -0.25 ± 0.92 | 0.25 ± 1.19 |
| Chest Pain, Week 67 | -0.18 ± 0.86 | 0.13 ± 1.44 |
| Chest Pain, Week 68 | -0.15 ± 0.93 | -0.25 ± 1.55 |
| Chest Pain, Week 69 | -0.13 ± 0.83 | -0.17 ± 1.89 |
| Chest Pain, Week 70 | -0.14 ± 0.93 | 0.00 ± 1.80 |
| Chest Pain, Week 71 | -0.10 ± 0.88 | 0.00 ± 0.87 |
| Chest Pain, Week 72 | -0.24 ± 0.85 | -1.00 ± 0.71 |
| Chest Pain, Week 73 | -0.25 ± 1.02 | -1.50 |
| Chest Pain, Week 74 | -0.08 ± 0.93 | -1.50 |
| Chest Pain, Week 75 | -0.21 ± 0.98 | -1.50 |
| Chest Pain, Week 76 | 0.03 ± 1.00 | -1.50 |
| Chest Pain, Week 77 | -0.06 ± 0.89 | -1.50 ± 0.00 |
| Chest Pain, Week 78 | -0.04 ± 0.84 | -1.50 |
| Chest Pain, Week 79 | -0.11 ± 1.09 | -0.50 |
| Chest Pain, Week 80 | -0.18 ± 1.05 | -1.50 |
| Chest Pain, Week 81 | -0.59 ± 0.96 | -1.50 |
| Chest Pain, Week 82 | -0.39 ± 0.96 | -1.50 |
| Chest Pain, Week 83 | -0.34 ± 0.90 | -1.50 |
| Chest Pain, Week 84 | -0.20 ± 0.75 | -1.50 |
| Chest Pain, Week 85 | -0.44 ± 0.97 | -1.50 |
| Chest Pain, Week 86 | -0.38 ± 0.64 | -1.50 |
| Chest Pain, Week 87 | -0.53 ± 1.01 | -1.50 |
| Chest Pain, Week 88 | -0.46 ± 1.06 | -1.50 |
| Chest Pain, Week 89 | -0.55 ± 0.96 | -1.50 |
| Chest Pain, Week 90 | -0.18 ± 0.85 | -1.50 |
| Chest Pain, Week 91 | -0.32 ± 1.08 | -1.50 |
| Chest Pain, Week 92 | -0.40 ± 0.66 | -1.50 |
| Chest Pain, Week 93 | -0.18 ± 1.08 | -1.50 |
| Chest Pain, Week 94 | -0.30 ± 1.09 | — |
| Chest Pain, Week 95 | -0.05 ± 1.26 | — |
| Chest Pain, Week 96 | -0.17 ± 1.25 | — |
| Chest Pain, Week 97 | -0.19 ± 1.31 | — |
| Chest Pain, Week 98 | -0.25 ± 1.16 | — |
| Chest Pain, Week 99 | -0.21 ± 1.47 | — |
| Chest Pain, Week 100 | -0.50 ± 1.38 | — |
| Chest Pain, Week 101 | -0.36 ± 1.38 | — |
| Chest Pain, Week 102 | -0.75 ± 1.71 | — |
| Chest Pain, Week 103 | -0.33 ± 1.54 | — |
| Chest Pain, Week 104 | -0.60 ± 1.39 | — |
| Chest Pain, Week 105 | -1.00 ± 1.41 | — |
| Chest Pain, Week 106 | -1.00 ± 1.41 | — |
| Chest Pain, Week 107 | -1.00 ± 1.41 | — |
| Chest Pain, Week 108 | -0.75 ± 1.50 | — |
| Chest Pain, Week 109 | -0.60 ± 1.52 | — |
| Chest Pain, Week 110 | -0.42 ± 1.43 | — |
| Chest Pain, Week 111 | -0.50 ± 1.50 | — |
| Chest Pain, Week 112 | -0.13 ± 0.63 | — |
| Chest Pain, Week 113 | 0.13 ± 0.63 | — |
| Chest Pain, Week 114 | 0.00 ± 1.00 | — |
| Chest Pain, Week 115 | 0.25 ± 0.35 | — |
| Chest Pain, Week 116 | 0.50 ± 0.71 | — |
| Chest Pain, Week 117 | 0.25 ± 1.06 | — |
| Chest Pain, Week 118 | -0.25 ± 1.06 | — |
| Chest Pain, Week 119 | -0.25 ± 0.35 | — |
| Chest Pain, Week 120 | 0.00 ± 0.71 | — |
| Chest Pain, Week 121 | 0.00 ± 1.41 | — |
| Chest Pain, Week 122 | 0.00 ± 1.41 | — |
| Chest Pain, Week 123 | -0.75 ± 1.77 | — |
| Chest Pain, Week 124 | 0.50 | — |
| Chest Pain, Week 125 | 0.50 | — |
| Chest Pain, Survival Follow-Up Month 1 | 0.01 ± 1.13 | 0.22 ± 0.87 |
| Chest Pain, Survival Follow-Up Month 2 | -0.07 ± 1.18 | -0.16 ± 0.96 |
| Chest Pain, Survival Follow-Up Month 3 | 0.15 ± 1.33 | -0.08 ± 0.87 |
| Chest Pain, Survival Follow-Up Month 4 | -0.28 ± 1.40 | -0.07 ± 0.79 |
| Chest Pain, Survival Follow-Up Month 5 | -0.11 ± 1.49 | -0.02 ± 0.65 |
| Chest Pain, Survival Follow-Up Month 6 | -0.37 ± 1.67 | 0.02 ± 0.78 |
| Cough, Week 1 | 0.08 ± 0.69 | 0.04 ± 0.73 |
| Cough, Week 2 | 0.02 ± 0.78 | 0.04 ± 0.84 |
| Cough, Week 3 | 0.02 ± 0.86 | -0.09 ± 0.93 |
| Cough, Week 4 | -0.06 ± 0.86 | -0.10 ± 0.93 |
| Cough, Week 5 | -0.09 ± 0.84 | -0.09 ± 0.99 |
| Cough, Week 6 | -0.15 ± 0.86 | -0.08 ± 0.98 |
| Cough, Week 7 | -0.11 ± 0.86 | -0.06 ± 1.01 |
| Cough, Week 8 | -0.13 ± 0.95 | -0.21 ± 1.04 |
| Cough, Week 9 | -0.15 ± 0.99 | -0.13 ± 1.23 |
| Cough, Week 10 | -0.20 ± 1.05 | -0.07 ± 1.17 |
| Cough, Week 11 | -0.15 ± 1.03 | -0.15 ± 1.17 |
| Cough, Week 12 | -0.17 ± 1.03 | -0.11 ± 1.09 |
| Cough, Week 13 | -0.24 ± 1.08 | -0.04 ± 1.11 |
| Cough, Week 14 | -0.23 ± 1.06 | -0.18 ± 1.08 |
| Cough, Week 15 | -0.27 ± 1.06 | -0.05 ± 1.10 |
| Cough, Week 16 | -0.37 ± 1.07 | -0.25 ± 1.09 |
| Cough, Week 17 | -0.32 ± 1.09 | -0.21 ± 1.01 |
| Cough, Week 18 | -0.33 ± 1.07 | -0.33 ± 1.09 |
| Cough, Week 19 | -0.33 ± 1.06 | -0.40 ± 0.89 |
| Cough, Week 20 | -0.37 ± 1.10 | -0.31 ± 0.90 |
| Cough, Week 21 | -0.37 ± 1.08 | -0.33 ± 0.96 |
| Cough, Week 22 | -0.37 ± 1.15 | -0.24 ± 0.97 |
| Cough, Week 23 | -0.30 ± 1.10 | -0.41 ± 1.03 |
| Cough, Week 24 | -0.38 ± 1.09 | -0.54 ± 1.04 |
| Cough, Week 25 | -0.49 ± 0.91 | -0.47 ± 1.05 |
| Cough, Week 26 | -0.43 ± 0.99 | -0.34 ± 1.02 |
| Cough, Week 27 | -0.41 ± 0.97 | -0.48 ± 0.98 |
| Cough, Week 28 | -0.52 ± 0.96 | -0.43 ± 0.84 |
| Cough, Week 29 | -0.43 ± 0.98 | -0.46 ± 0.91 |
| Cough, Week 30 | -0.43 ± 0.95 | -0.46 ± 1.07 |
| Cough, Week 31 | -0.32 ± 1.07 | -0.38 ± 0.77 |
| Cough, Week 32 | -0.30 ± 0.94 | -0.12 ± 0.99 |
| Cough, Week 33 | -0.19 ± 1.12 | -0.52 ± 1.03 |
| Cough, Week 34 | -0.35 ± 1.12 | -0.33 ± 1.03 |
| Cough, Week 35 | -0.46 ± 1.01 | 0.00 ± 1.22 |
| Cough, Week 36 | -0.35 ± 1.08 | -0.20 ± 1.01 |
| Cough, Week 37 | -0.46 ± 1.03 | -0.45 ± 1.11 |
| Cough, Week 38 | -0.38 ± 1.06 | -0.03 ± 0.89 |
| Cough, Week 39 | -0.27 ± 0.99 | -0.17 ± 1.00 |
| Cough, Week 40 | -0.38 ± 0.95 | -0.50 ± 0.90 |
| Cough, Week 41 | -0.44 ± 0.92 | -0.22 ± 0.77 |
| Cough, Week 42 | -0.44 ± 0.92 | -0.41 ± 0.97 |
| Cough, Week 43 | -0.39 ± 0.98 | -0.13 ± 0.92 |
| Cough, Week 44 | -0.38 ± 0.94 | -0.16 ± 0.89 |
| Cough, Week 45 | -0.30 ± 1.10 | -0.14 ± 1.03 |
| Cough, Week 46 | -0.25 ± 0.99 | -0.03 ± 1.23 |
| Cough, Week 47 | -0.44 ± 0.88 | -0.12 ± 1.23 |
| Cough, Week 48 | -0.29 ± 0.99 | 0.14 ± 1.21 |
| Cough, Week 49 | -0.38 ± 1.00 | -0.56 ± 1.36 |
| Cough, Week 50 | -0.39 ± 0.96 | -0.19 ± 1.16 |
| Cough, Week 51 | -0.30 ± 1.00 | -0.40 ± 1.20 |
| Cough, Week 52 | -0.32 ± 1.03 | -0.21 ± 1.07 |
| Cough, Week 53 | -0.37 ± 1.03 | -0.17 ± 1.33 |
| Cough, Week 54 | -0.41 ± 0.93 | -0.07 ± 1.21 |
| Cough, Week 55 | -0.40 ± 0.93 | 0.10 ± 1.34 |
| Cough, Week 56 | -0.26 ± 0.94 | 0.17 ± 1.13 |
| Cough, Week 57 | -0.35 ± 0.98 | 0.00 ± 1.27 |
| Cough, Week 58 | -0.33 ± 1.06 | 0.13 ± 1.31 |
| Cough, Week 59 | -0.31 ± 0.97 | 0.13 ± 1.60 |
| Cough, Week 60 | -0.42 ± 0.89 | 0.38 ± 1.18 |
| Cough, Week 61 | -0.35 ± 0.95 | 0.80 ± 1.20 |
| Cough, Week 62 | -0.23 ± 1.03 | 0.50 ± 1.62 |
| Cough, Week 63 | -0.22 ± 1.04 | 0.50 ± 1.27 |
| Cough, Week 64 | -0.19 ± 1.07 | 0.00 ± 1.87 |
| Cough, Week 65 | -0.23 ± 1.04 | 0.83 ± 1.04 |
| Cough, Week 66 | -0.29 ± 0.90 | 0.63 ± 1.03 |
| Cough, Week 67 | -0.48 ± 0.91 | 0.38 ± 1.38 |
| Cough, Week 68 | -0.34 ± 0.82 | 0.13 ± 1.49 |
| Cough, Week 69 | -0.34 ± 1.03 | 0.17 ± 1.61 |
| Cough, Week 70 | -0.26 ± 0.94 | 0.17 ± 1.61 |
| Cough, Week 71 | -0.23 ± 0.91 | 0.33 ± 1.04 |
| Cough, Week 72 | -0.48 ± 0.87 | -1.50 ± 1.41 |
| Cough, Week 73 | -0.43 ± 0.91 | -0.50 |
| Cough, Week 74 | -0.42 ± 0.93 | -0.50 |
| Cough, Week 75 | -0.32 ± 1.00 | -0.50 |
| Cough, Week 76 | -0.31 ± 0.91 | -0.50 |
| Cough, Week 77 | -0.40 ± 0.92 | -0.50 ± 2.83 |
| Cough, Week 78 | -0.52 ± 0.94 | 0.00 |
| Cough, Week 79 | -0.08 ± 0.93 | 1.00 |
| Cough, Week 80 | -0.48 ± 0.87 | 1.00 |
| Cough, Week 81 | -0.44 ± 1.01 | -0.50 |
| Cough, Week 82 | -0.39 ± 0.90 | 1.00 |
| Cough, Week 83 | -0.25 ± 1.09 | 0.50 |
| Cough, Week 84 | -0.30 ± 0.91 | 1.00 |
| Cough, Week 85 | -0.32 ± 1.25 | 1.50 |
| Cough, Week 86 | -0.54 ± 1.27 | 0.00 |
| Cough, Week 87 | -0.33 ± 1.18 | 0.00 |
| Cough, Week 88 | -0.46 ± 1.26 | 0.00 |
| Cough, Week 89 | -0.36 ± 1.07 | 0.00 |
| Cough, Week 90 | -0.29 ± 1.05 | 0.00 |
| Cough, Week 91 | -0.27 ± 1.17 | 0.00 |
| Cough, Week 92 | -0.35 ± 1.27 | 1.00 |
| Cough, Week 93 | -0.55 ± 0.96 | 0.00 |
| Cough, Week 94 | -0.40 ± 0.81 | — |
| Cough, Week 95 | 0.05 ± 1.23 | — |
| Cough, Week 96 | -0.28 ± 1.28 | — |
| Cough, Week 97 | -0.31 ± 1.19 | — |
| Cough, Week 98 | -0.10 ± 0.99 | — |
| Cough, Week 99 | -0.43 ± 0.98 | — |
| Cough, Week 100 | -0.58 ± 0.86 | — |
| Cough, Week 101 | -0.50 ± 0.96 | — |
| Cough, Week 102 | -0.50 ± 0.41 | — |
| Cough, Week 103 | -0.75 ± 0.42 | — |
| Cough, Week 104 | -0.80 ± 0.27 | — |
| Cough, Week 105 | -0.63 ± 0.48 | — |
| Cough, Week 106 | -0.63 ± 0.48 | — |
| Cough, Week 107 | -0.63 ± 0.48 | — |
| Cough, Week 108 | -0.50 ± 0.71 | — |
| Cough, Week 109 | -0.50 ± 0.50 | — |
| Cough, Week 110 | -0.50 ± 0.45 | — |
| Cough, Week 111 | -0.30 ± 0.84 | — |
| Cough, Week 112 | -0.63 ± 0.48 | — |
| Cough, Week 113 | -0.25 ± 0.65 | — |
| Cough, Week 114 | -0.33 ± 0.29 | — |
| Cough, Week 115 | 0.25 ± 0.35 | — |
| Cough, Week 116 | -0.25 ± 1.06 | — |
| Cough, Week 117 | -0.50 ± 0.71 | — |
| Cough, Week 118 | -0.25 ± 0.35 | — |
| Cough, Week 119 | 0.00 ± 0.00 | — |
| Cough, Week 120 | -0.25 ± 0.35 | — |
| Cough, Week 121 | -0.50 ± 0.71 | — |
| Cough, Week 122 | -0.50 ± 0.71 | — |
| Cough, Week 123 | -0.75 ± 1.06 | — |
| Cough, Week 124 | 0.50 | — |
| Cough, Week 125 | 0.50 | — |
| Cough, Survival Follow-Up Month 1 | -0.21 ± 1.05 | -0.01 ± 0.96 |
| Cough, Survival Follow-Up Month 2 | -0.07 ± 1.16 | -0.31 ± 1.18 |
| Cough, Survival Follow-Up Month 3 | -0.14 ± 1.12 | -0.13 ± 1.32 |
| Cough, Survival Follow-Up Month 4 | -0.39 ± 1.15 | -0.45 ± 1.17 |
| Cough, Survival Follow-Up Month 5 | -0.25 ± 1.44 | -0.27 ± 1.32 |
| Cough, Survival Follow-Up Month 6 | -0.23 ± 1.53 | -0.29 ± 1.26 |
| Dyspnoea, Week 1 | 0.13 ± 0.76 | 0.23 ± 0.79 |
| Dyspnoea, Week 2 | 0.10 ± 0.68 | 0.31 ± 0.84 |
| Dyspnoea, Week 3 | 0.22 ± 0.78 | 0.32 ± 0.76 |
| Dyspnoea, Week 4 | 0.23 ± 0.80 | 0.45 ± 0.84 |
| Dyspnoea, Week 5 | 0.26 ± 0.84 | 0.42 ± 0.92 |
| Dyspnoea, Week 6 | 0.27 ± 0.92 | 0.51 ± 0.95 |
| Dyspnoea, Week 7 | 0.29 ± 0.88 | 0.60 ± 1.00 |
| Dyspnoea, Week 8 | 0.32 ± 0.97 | 0.53 ± 1.02 |
| Dyspnoea, Week 9 | 0.38 ± 0.95 | 0.62 ± 1.07 |
| Dyspnoea, Week 10 | 0.41 ± 1.04 | 0.75 ± 1.13 |
| Dyspnoea, Week 11 | 0.50 ± 1.05 | 0.60 ± 1.06 |
| Dyspnoea, Week 12 | 0.47 ± 1.07 | 0.74 ± 1.08 |
| Dyspnoea, Week 13 | 0.32 ± 1.00 | 0.76 ± 1.00 |
| Dyspnoea, Week 14 | 0.34 ± 0.99 | 0.61 ± 1.10 |
| Dyspnoea, Week 15 | 0.29 ± 1.06 | 0.71 ± 1.02 |
| Dyspnoea, Week 16 | 0.22 ± 0.99 | 0.67 ± 1.11 |
| Dyspnoea, Week 17 | 0.28 ± 1.10 | 0.68 ± 1.03 |
| Dyspnoea, Week 18 | 0.23 ± 1.02 | 0.62 ± 1.03 |
| Dyspnoea, Week 19 | 0.26 ± 1.06 | 0.54 ± 0.95 |
| Dyspnoea, Week 20 | 0.24 ± 1.02 | 0.54 ± 1.08 |
| Dyspnoea, Week 21 | 0.26 ± 1.04 | 0.39 ± 1.05 |
| Dyspnoea, Week 22 | 0.21 ± 0.94 | 0.41 ± 1.05 |
| Dyspnoea, Week 23 | 0.18 ± 0.97 | 0.41 ± 1.06 |
| Dyspnoea, Week 24 | 0.22 ± 0.93 | 0.31 ± 1.01 |
| Dyspnoea, Week 25 | 0.21 ± 0.88 | 0.20 ± 0.91 |
| Dyspnoea, Week 26 | 0.17 ± 0.89 | 0.30 ± 1.00 |
| Dyspnoea, Week 27 | 0.20 ± 1.04 | 0.30 ± 0.92 |
| Dyspnoea, Week 28 | 0.16 ± 0.94 | 0.22 ± 1.01 |
| Dyspnoea, Week 29 | 0.16 ± 0.92 | 0.33 ± 0.98 |
| Dyspnoea, Week 30 | 0.24 ± 1.04 | 0.27 ± 1.02 |
| Dyspnoea, Week 31 | 0.12 ± 0.99 | 0.26 ± 1.04 |
| Dyspnoea, Week 32 | 0.20 ± 0.95 | 0.38 ± 1.06 |
| Dyspnoea, Week 33 | 0.18 ± 0.98 | 0.19 ± 1.14 |
| Dyspnoea, Week 34 | 0.21 ± 1.06 | 0.30 ± 1.02 |
| Dyspnoea, Week 35 | 0.22 ± 1.03 | 0.46 ± 0.96 |
| Dyspnoea, Week 36 | 0.21 ± 1.09 | 0.34 ± 1.14 |
| Dyspnoea, Week 37 | 0.16 ± 1.13 | 0.10 ± 1.07 |
| Dyspnoea, Week 38 | 0.18 ± 1.07 | 0.51 ± 0.99 |
| Dyspnoea, Week 39 | 0.31 ± 1.04 | 0.26 ± 0.83 |
| Dyspnoea, Week 40 | 0.31 ± 0.99 | 0.04 ± 0.79 |
| Dyspnoea, Week 41 | 0.24 ± 0.99 | 0.18 ± 0.85 |
| Dyspnoea, Week 42 | 0.26 ± 1.03 | 0.08 ± 0.70 |
| Dyspnoea, Week 43 | 0.17 ± 1.13 | 0.41 ± 0.91 |
| Dyspnoea, Week 44 | 0.22 ± 1.06 | 0.29 ± 0.86 |
| Dyspnoea, Week 45 | 0.26 ± 1.09 | 0.31 ± 0.90 |
| Dyspnoea, Week 46 | 0.29 ± 0.99 | 0.47 ± 1.03 |
| Dyspnoea, Week 47 | 0.20 ± 1.02 | 0.45 ± 0.85 |
| Dyspnoea, Week 48 | 0.32 ± 1.00 | 0.29 ± 0.91 |
| Dyspnoea, Week 49 | 0.24 ± 1.04 | 0.00 ± 1.30 |
| Dyspnoea, Week 50 | 0.32 ± 0.98 | 0.43 ± 0.88 |
| Dyspnoea, Week 51 | 0.24 ± 0.92 | 0.06 ± 1.04 |
| Dyspnoea, Week 52 | 0.27 ± 0.95 | 0.29 ± 0.90 |
| Dyspnoea, Week 53 | 0.24 ± 1.00 | 0.30 ± 0.85 |
| Dyspnoea, Week 54 | 0.28 ± 0.89 | 0.40 ± 0.95 |
| Dyspnoea, Week 55 | 0.26 ± 0.98 | 0.44 ± 1.02 |
| Dyspnoea, Week 56 | 0.26 ± 0.97 | 0.53 ± 1.10 |
| Dyspnoea, Week 57 | 0.37 ± 0.95 | 0.24 ± 1.08 |
| Dyspnoea, Week 58 | 0.19 ± 1.01 | 0.35 ± 1.40 |
| Dyspnoea, Week 59 | 0.32 ± 0.84 | 0.35 ± 1.40 |
| Dyspnoea, Week 60 | 0.35 ± 0.99 | 0.50 ± 1.51 |
| Dyspnoea, Week 61 | 0.33 ± 1.03 | 0.60 ± 1.40 |
| Dyspnoea, Week 62 | 0.45 ± 0.99 | 0.72 ± 1.36 |
| Dyspnoea, Week 63 | 0.44 ± 1.05 | 0.56 ± 1.35 |
| Dyspnoea, Week 64 | 0.36 ± 0.98 | -0.50 ± 1.91 |
| Dyspnoea, Week 65 | 0.27 ± 0.97 | 0.07 ± 1.68 |
| Dyspnoea, Week 66 | 0.32 ± 1.11 | 0.50 ± 1.23 |
| Dyspnoea, Week 67 | 0.28 ± 0.91 | 0.40 ± 1.36 |
| Dyspnoea, Week 68 | 0.35 ± 0.96 | 0.40 ± 1.43 |
| Dyspnoea, Week 69 | 0.44 ± 1.02 | 0.73 ± 1.55 |
| Dyspnoea, Week 70 | 0.33 ± 0.97 | 0.73 ± 1.55 |
| Dyspnoea, Week 71 | 0.50 ± 0.95 | 0.60 ± 1.51 |
| Dyspnoea, Week 72 | 0.17 ± 0.95 | 0.60 ± 1.44 |
| Dyspnoea, Week 73 | 0.41 ± 0.96 | -1.80 ± 1.13 |
| Dyspnoea, Week 74 | 0.30 ± 1.00 | -1.00 |
| Dyspnoea, Week 75 | 0.26 ± 0.89 | -1.00 |
| Dyspnoea, Week 76 | 0.23 ± 0.89 | -1.00 |
| Dyspnoea, Week 77 | 0.20 ± 0.97 | -1.50 ± 1.56 |
| Dyspnoea, Week 78 | 0.31 ± 0.94 | -1.00 |
| Dyspnoea, Week 79 | 0.32 ± 0.95 | -1.00 |
| Dyspnoea, Week 80 | 0.30 ± 0.92 | -1.00 |
| Dyspnoea, Week 81 | -0.12 ± 1.00 | -0.80 |
| Dyspnoea, Week 82 | 0.02 ± 1.06 | -0.80 |
| Dyspnoea, Week 83 | 0.13 ± 1.01 | -1.00 |
| Dyspnoea, Week 84 | 0.19 ± 1.00 | -1.00 |
| Dyspnoea, Week 85 | 0.05 ± 1.17 | -0.80 |
| Dyspnoea, Week 86 | -0.07 ± 1.05 | -1.00 |
| Dyspnoea, Week 87 | -0.11 ± 0.96 | -1.00 |
| Dyspnoea, Week 88 | 0.06 ± 1.12 | -1.00 |
| Dyspnoea, Week 89 | 0.09 ± 0.91 | -1.00 |
| Dyspnoea, Week 90 | 0.37 ± 0.83 | -1.00 |
| Dyspnoea, Week 91 | 0.33 ± 1.11 | -1.00 |
| Dyspnoea, Week 92 | 0.20 ± 1.05 | -0.80 |
| Dyspnoea, Week 93 | 0.35 ± 0.96 | -0.80 |
| Dyspnoea, Week 94 | 0.50 ± 0.93 | — |
| Dyspnoea, Week 95 | 0.48 ± 0.98 | — |
| Dyspnoea, Week 96 | 0.51 ± 1.09 | — |
| Dyspnoea, Week 97 | 0.33 ± 1.18 | — |
| Dyspnoea, Week 98 | 0.38 ± 1.05 | — |
| Dyspnoea, Week 99 | 0.11 ± 0.99 | — |
| Dyspnoea, Week 100 | 0.27 ± 1.11 | — |
| Dyspnoea, Week 101 | 0.20 ± 1.11 | — |
| Dyspnoea, Week 102 | 0.35 ± 1.06 | — |
| Dyspnoea, Week 103 | 0.47 ± 1.29 | — |
| Dyspnoea, Week 104 | 0.48 ± 1.22 | — |
| Dyspnoea, Week 105 | -0.20 ± 0.71 | — |
| Dyspnoea, Week 106 | -0.20 ± 0.99 | — |
| Dyspnoea, Week 107 | -0.30 ± 0.62 | — |
| Dyspnoea, Week 108 | -0.15 ± 0.98 | — |
| Dyspnoea, Week 109 | 0.16 ± 1.17 | — |
| Dyspnoea, Week 110 | 0.33 ± 1.00 | — |
| Dyspnoea, Week 111 | -0.04 ± 0.86 | — |
| Dyspnoea, Week 112 | 0.20 ± 0.43 | — |
| Dyspnoea, Week 113 | 0.20 ± 0.67 | — |
| Dyspnoea, Week 114 | 0.40 ± 0.72 | — |
| Dyspnoea, Week 115 | 0.80 ± 0.85 | — |
| Dyspnoea, Week 116 | 0.60 ± 0.57 | — |
| Dyspnoea, Week 117 | 0.30 ± 0.14 | — |
| Dyspnoea, Week 118 | 0.30 ± 0.42 | — |
| Dyspnoea, Week 119 | 0.50 ± 0.42 | — |
| Dyspnoea, Week 120 | 0.30 ± 0.42 | — |
| Dyspnoea, Week 121 | 0.60 ± 0.57 | — |
| Dyspnoea, Week 122 | 0.60 ± 0.00 | — |
| Dyspnoea, Week 123 | -0.20 ± 0.57 | — |
| Dyspnoea, Week 124 | -0.20 | — |
| Dyspnoea, Week 125 | 0.20 | — |
| Dyspnoea, Survival Follow-Up Month 1 | 0.41 ± 1.11 | 0.60 ± 1.14 |
| Dyspnoea, Survival Follow-Up Month 2 | 0.36 ± 1.20 | 0.46 ± 1.22 |
| Dyspnoea, Survival Follow-Up Month 3 | 0.27 ± 0.96 | 0.61 ± 1.19 |
| Dyspnoea, Survival Follow-Up Month 4 | 0.02 ± 1.11 | 0.45 ± 0.88 |
| Dyspnoea, Survival Follow-Up Month 5 | 0.13 ± 1.24 | 0.48 ± 1.00 |
| Dyspnoea, Survival Follow-Up Month 6 | -0.09 ± 1.29 | 0.54 ± 0.97 |
Percentage of participants with at least one adverse event. Adverse event onset date before cross over.
| Percentage of participants | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
|---|---|---|
| Percentage of Participants With Adverse Events | 99.6 | 98.7 |
Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B Carboplatin+nab-paclitaxel Crossover Participants
| Perecentage of participants | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) |
|---|---|---|
| Baseline | 3.1 | 4.8 |
| Post-baseline | 22.4 | 23.5 |
Predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.
| mcg/mL | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) |
|---|---|
| Cycle 1 Day 1 | 392 ± 114 |
| Cycle 3 Day 1 | 454 ± 170 |
Predose samples will be collected on the same day of treatment administration.
| mcg/mL | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) |
|---|---|
| Cycle 1 Day 21 | 70.9 ± 35.1 |
| Cycle 2 Day 21 | 111 ± 52.2 |
| Cycle 3 Day 21 | 134 ± 57.8 |
| Cycle 7 Day 21 | 218 ± 93.7 |
| ng/mL | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin Crossover) |
|---|---|---|
| Cycle 1 Day 1 Pre-dose | NA ± NA | NA ± NA |
| Cycle 1 Day 1 Before End of Infusion | 20,500 ± 7500 | 17,000 ± 5200 |
| Cycle 1 Day 1 Post Infusion | 11,900 ± 3100 | 12,400 ± 3800 |
| Cycle 3 Day 1 Pre-dose | 169 ± 63.8 | 160 ± 48.8 |
| Cycle 3 Day 1 Before End of Infusion | 15,300 ± 6600 | 17,800 ± 7550 |
| Cycle 3 Day 1 Post Infusion | 11,400 ± 3060 | 13,400 ± 6650 |
| ng/mL | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin Crossover) |
|---|---|---|
| Cycle 1 Day 1 Pre-dose | NA ± NA | NA ± NA |
| Cycle 1 Day 1 Before End of Infusion | 3520 ± 2210 | 2530 ± 1420 |
| Cycle 1 Day 1 Post Infusion | 307 ± 153 | 417 ± 217 |
| Cycle 3 Day 1 Pre-dose | NA ± NA | NA ± NA |
| Cycle 3 Day 1 Before End of Infusion | 4480 ± 3520 | 2030 ± 1690 |
| Cycle 3 Day 1 Post Infusion | 357 ± 253 | 447 ± 322 |
Collected over From the first study drug to the data cutoff date: 18 January 2021 (approximately 69 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | 338/473 (71.5%) | 252/473 (53.3%) | 467/473 (98.7%) |
| Arm B Without Crossover Participants (Nab-Paclitaxel+Carboplatin) | 108/131 (82.4%) | 63/131 (48.1%) | 127/131 (96.9%) |
| Arm B With Crossover Participants (Nab-Paclitaxel+Carboplatin, After Crossover Atezo Monotherapy) | 70/101 (69.3%) | 24/101 (23.8%) | 100/101 (99%) |
| Event | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B Without Crossover Participants (Nab-Paclitaxel+Carboplatin) | Arm B With Crossover Participants (Nab-Paclitaxel+Carboplatin, After Crossover Atezo Monotherapy) |
|---|---|---|---|
| PNEUMONIAInfections and infestations | 45/473 | 13/131 | 2/101 |
| ANAEMIABlood and lymphatic system disorders | 14/473 | 4/131 | 4/101 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASERespiratory, thoracic and mediastinal disorders | 13/473 | 5/131 | 0/101 |
| PULMONARY EMBOLISMRespiratory, thoracic and mediastinal disorders | 17/473 | 3/131 | 2/101 |
| NEUTROPENIABlood and lymphatic system disorders | 14/473 | 1/131 | 1/101 |
| DIARRHOEAGastrointestinal disorders | 14/473 | 1/131 | 1/101 |
| DYSPNOEARespiratory, thoracic and mediastinal disorders | 12/473 | 1/131 | 0/101 |
| FEBRILE NEUTROPENIABlood and lymphatic system disorders | 9/473 | 3/131 | 2/101 |
| NAUSEAGastrointestinal disorders | 5/473 | 3/131 | 1/101 |
| VOMITINGGastrointestinal disorders | 6/473 | 3/131 | 1/101 |
| Event | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B Without Crossover Participants (Nab-Paclitaxel+Carboplatin) | Arm B With Crossover Participants (Nab-Paclitaxel+Carboplatin, After Crossover Atezo Monotherapy) |
|---|---|---|---|
| ANAEMIABlood and lymphatic system disorders | 259/473 | 67/131 | 50/101 |
| NEUTROPENIABlood and lymphatic system disorders | 213/473 | 52/131 | 53/101 |
| FATIGUEGeneral disorders | 228/473 | 57/131 | 52/101 |
| NAUSEAGastrointestinal disorders | 236/473 | 61/131 | 44/101 |
| DIARRHOEAGastrointestinal disorders | 196/473 | 37/131 | 35/101 |
| CONSTIPATIONGastrointestinal disorders | 176/473 | 38/131 | 33/101 |
| ALOPECIASkin and subcutaneous tissue disorders | 152/473 | 33/131 | 30/101 |
| THROMBOCYTOPENIABlood and lymphatic system disorders | 132/473 | 29/131 | 31/101 |
| DECREASED APPETITEMetabolism and nutrition disorders | 144/473 | 34/131 | 30/101 |
| COUGHRespiratory, thoracic and mediastinal disorders | 135/473 | 21/131 | 18/101 |
| Age, Continuous(Years) | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) | Total |
|---|---|---|---|
| Mean | 63.8 ± 9.5 | 64.4 ± 8.9 | 64.0 ± 9.3 |
| Sex: Female, Male(Participants) | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) | Total |
|---|---|---|---|
| Female | 206 | 102 | 308 |
| Male | 277 | 138 | 415 |
| Ethnicity (NIH/OMB)(Participants) | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) | Total |
|---|---|---|---|
| Hispanic or Latino | 25 | 12 | 37 |
| Not Hispanic or Latino | 426 | 213 | 639 |
| Unknown or Not Reported | 32 | 15 | 47 |
| Race (NIH/OMB)(Participants) | Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) | Arm B (Nab-Paclitaxel+Carboplatin) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 14 | 3 | 17 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 18 | 8 | 26 |
| White | 428 | 222 | 650 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 21 | 7 | 28 |
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